This study examines nasoalveolar molding (NAM), a relatively new and highly controversial, pre-surgical treatment aimed at improving cosmetic and functional outcomes among children with cleft lip and palate (CLP) through early intervention at about one month of age. NAM is intended to reduce the severity of initial cleft deformity through the use of surgical tape, molding plates, and nasal stents. It has polarized professionals in the field of craniofacial habilitation because of the additional demands NAM care places on caregivers (parents) who have infants with CLP. For example, caregivers {(CGs)} are responsible for the daily care of the appliance, positioning of tape, and attending weekly clinic appointments for 3-5 months. Scant data exist, however, on the impact of NAM on family functioning. This research will examine caregivers' decision-making and responses to early cleft care in a prospective, longitudinal, quantitative and qualitative study of primary CGs of children with CLP at {four} renowned craniofacial centers: New York University (NYU), the University of North Carolina- Chapel Hill (UNC), {Oregon Health and Science University (OHSU), and Children's Healthcare of Atlanta (CHOA)}. This study will be the first to compare the stress and family cohesion of two CG groups: (Group 1- {(n~60)} CGs whose infants with CLP have NAM and standard cleft surgery; and Group 2- {(n~60)} CGs whose infants with CLP undergo standard cleft surgery only. Our specific aims are: 1) To assess parental stress and family cohesion among CGs whose infants receive NAM and those CGs whose infants receive traditional cleft care using the Parent Stress Index (PSI) and Family Relationship Index of the Family Environment Scale (FES) and to compare the pattern of changes over time in PSI and FES, within and between the two treatment groups {while controlling for center and potential confounders like CG coping, depression, and optimism}; and 2: To examine subjective responses to treatment-related decision-making and cleft care by conducting semi- structured interviews with CGs whose infants with CLP undergo NAM and CGs whose infants with CLP do not undergo NAM (i.e., traditional cleft care without NAM) and to compare the pattern of responses over time, within and between the two treatment groups. {We will explore the interrelationships among sociodemographic factors (e.g., number of children in the home, infants' birth order, insurance), clinical factors (e.g., extent of defect), caregiver characteristics (e.g., depression, anxiety, optimism) and possible site differences using quantitative and qualitative analyses. Data will be collected at three time points: initial clinic visit; pre-lip surgery; and post- secondary palate surgery. In addition to gaining insight into decision-making, responses to care, and the foundation of quality of life among families having children with cleft, this study may} help to identify potential interventions aimed at enhancing family well-being and health-related quality of life in cleft care. PUBLIC HEALTH RELEVANCE: This study examines nasoalveolar molding (NAM), a relatively new and controversial, pre- surgical treatment aimed at improving cosmetic and functional outcomes among children with cleft lip and palate (CLP) through early intervention at about one month of age. Specifically, this study compares caregiver responses to early cleft care (NAM plus traditional cleft surgery versus traditional surgery). The findings will provide insight into the interrelationships among decision-making regarding medical treatment, caregiver psychosocial characteristics, extent of defect, demographic variables, contextual factors and parental stress.